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Trial record 81 of 727 for:    Area Under Curve AND Bioavailability

Regular Consumption of High Phytate Reduces Inhibitory Effect of Phytate on Iron Absorption

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ClinicalTrials.gov Identifier: NCT02370940
Recruitment Status : Completed
First Posted : February 25, 2015
Last Update Posted : February 25, 2015
Sponsor:
Collaborator:
HarvestPlus
Information provided by (Responsible Party):
Dr. Manju B. Reddy, Iowa State University

Brief Summary:
The purpose of this study is to investigate whether regular consumption of phytate dampens its negative effect on nonheme iron absorption.

Condition or disease Intervention/treatment Phase
Iron Bioavailability Other: High phytate intake Other: Low phytate intake Not Applicable

Detailed Description:
Phytate is one of the main inhibitors of nonheme iron absorption. High phytate consumption is of concern in developing countries because of the high prevalence of iron and zinc deficiency in these countries. In this study, we investigated the effect of habitual consumption of a high phytate diet on the inhibitory effect of phytate on nonheme iron absorption. Thirty-two non-anemic female subjects with ferritin ≤ 30µg/L were randomized into two groups, after matching for ferritin concentration. Each group consumed either high or low phytate foods that were provided for 8 wk. Iron bioavailability from a high phytate test meal was measured using area under the curve (AUC) for serum iron at baseline and after the intervention.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 32 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Official Title: Regular Consumption of High Phytate Diet Reduces Inhibitory Effect of Phytate on Nonheme Iron Absorption in Female Subjects
Study Start Date : January 2013
Actual Primary Completion Date : April 2013
Actual Study Completion Date : April 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Iron

Arm Intervention/treatment
Experimental: High Phytate Diet
The high phytate diet group was required to consume a high phytate diet for 8 weeks. The high phytate foods were provided for subjects. They received whole grain ready-to-eat cereals, whole wheat pasta/spaghetti, tortillas, bagels, bread and dinner rolls, corn tortillas, brown rice, canned black beans, edamame and tofu, and were encouraged to consume generous amounts of nuts and other legume products high in phytate.
Other: High phytate intake
Experimental: Low Phytate Diet
The low phytate diet group was required to consume a low phytate diet for 8 weeks. They received foods similar to those for the high phytate diet group but which were made from refined wheat and white rice, eggs and cheese, and were instructed to avoid high phytate foods.
Other: Low phytate intake



Primary Outcome Measures :
  1. Area under the curve for serum iron for assessing bioavailability [ Time Frame: 8 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Marginal iron status (Serum ferritin <30ug/L)
  • BMI in the range 18.5-24.9kg/m2
  • Willing to modify diet to increase or decrease phytate intake
  • Willing to give multiple blood samples at beginning and end of study

Exclusion Criteria:

  • Pregnant
  • Lactating
  • Smoker
  • Anemic (hemoglobin <120 g/L)
  • Has gastro-intestinal disease/condition that can affect absorption

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02370940


Sponsors and Collaborators
Iowa State University
HarvestPlus
Investigators
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Principal Investigator: Manju B Reddy, PhD Iowa State University

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr. Manju B. Reddy, Professor, Iowa State University
ClinicalTrials.gov Identifier: NCT02370940     History of Changes
Other Study ID Numbers: IPAAD Study
First Posted: February 25, 2015    Key Record Dates
Last Update Posted: February 25, 2015
Last Verified: February 2015
Keywords provided by Dr. Manju B. Reddy, Iowa State University:
Iron bioavailability
phytate
serum iron curve
hepcidin
iron status
Additional relevant MeSH terms:
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Iron
Trace Elements
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs